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Collection content
116 result(s) found, displaying 11 to 20
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PagePharmaceutical companies Novo Nordisk and Eli Lilly are gradually discontinuing some of their earlier generation insulin products. Our webpage lists affected products and includes alternative options.
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BlogYou might see a good deal on an overseas website, however, these health products are not approved for supply in Australia and have not been assessed by the TGA for safety, quality or effectiveness. You are not only risking your health, but you may also be left out of pocket if your online purchase is stopped at the border.
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
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PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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PageInformation on proposing a new ingredient name to be included on the approved list.
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PageGLP-1 receptor agonists such as Ozempic (semaglutide) and its derivatives are regulated as prescription-only medicines.
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PageApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.